DeviceClearance

Product code MTV— General Hospital

NeedleSmart Professional (NS Pro)

Classification name
Sharps Needle Destruction Device
Device class
Class 2
Regulation
21 CFR 880.6210
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification definition

“A prescription device that is intended to destroy needles or sharps used for medical purposes by incineration or mechanical means.”

— U.S. Food and Drug Administration, device classification record for product code MTV under 21 CFR 880.6210, via openFDA

Market context for product code MTV

FDA has cleared 1 device under product code MTV, all in 2021, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code MTV

Recent clearances under product code MTV

Data sourced from openFDA. This site is unofficial and independent of the FDA.